Regulators in the US have approved an expanded use of Celgene’s oncology drug Abraxane, giving it the green light to be used against pancreatic cancer.
The US Food and Drug Administration (FDA) recommended Abraxane be available as a first-line treatment for patient with metastatic adenocarcinoma of the pancreas, in combination with Lilly’s Gemzar (gemcitabine).
It adds to Abraxane’s existing cancer indications for use in the treatment of metastatic breast cancer and advanced non-small cell lung cancer (NSCLC), for which it managed sales of $155m for the second quarter of 2013, coming primarily from the US.
Metastatic adenocarcinoma of the pancreas is classified as a rare disease in the US, meaning Abraxane’s approval is under orphan drug status, which offers incentives such as tax breaks for companies researching drugs in this area.
Further to this, the FDA also put Abraxane through its priority review programme to expedite the review process for drugs that offer significant improvement in the treatment, prevention or diagnosis of a condition.
This applied to Abraxane as clinical trials demonstrated that patients treated with Abraxane plus Gemzar lived, on average, 1.8 months longer than those treated with Gemzar alone. Abraxane patients in the study also experienced a delay in tumour growth.
These positive results were especially significant as Gemzar has been the standard of care for more than 15 years for patients with with metastatic adenocarcinoma of the pancreas and new treatments are sorely needed.
“We are pleased that patients with advanced pancreatic cancer now have a new treatment option helping to expand the treatment landscape for the fourth leading cause of cancer death in the US,” said Julie Fleshman, president and CEO of the Pancreatic Cancer Action Network.
“The FDA approval of Abraxane is an important step for a disease that desperately needs treatment advances to improve patient outcomes,” she added.